FDA Defines Apple Watch As a Wellness Tool, NOT a Medical Device

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Apple

Apple

The Apple Watch was announced roughly nine months after company executives met with representatives from the United States Food and Drug Administration (FDA) to discuss how new, innovative products with sensors, would be regulated.

Now that wearable are becoming increasingly more popular, the FDA has published a draft, “General Wellness: Policy for Low Risk Devices,” clarifying whether or not devices such as the Apple Watch should be considered medical devices.

The Apple Watch will fall under the “general wellness” category because wearable devices are only labeled medical devices when they can treat specific diseases or conditions.

While it is not technically a medical device, the watch can still help out in the healthcare department of general wellness which encompasses devices that are related to weight management, physical fitness, relaxation or stress management, self-esteem, mental acuity, sexual function, or sleep management.

A medical device on the other hand can treat things like anxiety, obesity, eating disorders, and muscle atrophy to name a few examples.

The Apple Watch comes equipped with tracking tools designed to motivate users to “stand”, “exercise”, and “move”.

While the watch is not deemed a medical device, the “general wellness” label is just fine by Apple because the Apple Watch is exempt from the 2.3 percent medical device tax, part of the U.S. Affordable Care Act.

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